Abstract
Abstract Aims According to new Guidelines, the use of an anti-PCSK9 monoclonal antibody in combination is recommended in secondary prevention in patients with very high risk who do not reach the target with the maximum tolerated dose of statin and ezetimibe, and in those patients with very high-risk familial hypercholesterolemia. The therapy is always combination, while the single treatment with anti-PCSK9 monoclonal antibody is indicated in patients with statin intolerance. The present study aims to determine the cardiovascular effects that are highlighted in the treatment of dyslipidaemia with the anti-PCSK9 monoclonal antibody, especially as regards the endothelial function (using the non-invasive methods of EndoPAT), the arterial stiffness (using the non-invasive methods of SphygmoCOR) and the effective improvement on the lipid profile (reduction total cholesterol, LDL and triglycerides). Methods The study is a single-centre prospective study enrolling 47 patients in primary and secondary prevention with non-target LDL cholesterol. Patients were evaluated and enrolled from April 2019 to June 2020 (recruitment period). The average follow-up was 12 weeks, from intaking one of anti-PCSK9, Alirocumab 75 or 150 mg and Evolocumab 140 mg. The scheduled evaluations of the enrolled population were before the beginning of the therapy and after a period of 12 weeks. Results After 12 weeks of treatment we demonstrated a statistically significant reduction in total cholesterol (P < 0.001) and LDL (P < 0.001). An important effect on the inflammatory profile was highlighted, resulting in a decrease in Hs-CRP at 12-weeks (P 0.057), associated with an improvement on endothelial function (P 0.003). Reduction of arterial stiffness was no significant (P 0.238). Conclusions Data confirm anti-PCSK9 monoclonal antibodies, associated with statins and/or ezetimibe to reach LDL target, improve significantly lipid profile and endothelial function. Furthermore anti-PCSK9 monoclonal antibodies are safe and practically free of side effects.
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